Systems and methods for fixing soft tissue

ABSTRACT

Embodiments of systems and methods for fixing soft tissue are disclosed herein. In some embodiments, soft tissue may be fixed to an attachment surface (such as bone, other soft tissue, other implants, or allograft or xenograft materials) by providing a helical suture in the soft tissue, wherein the soft tissue has a longitudinal axis along which the soft tissue undergoes tension under normal physiological conditions, and wherein a longitudinal axis of the helical suture in the soft tissue is oriented parallel to the longitudinal axis of the soft tissue; and securing the helical suture to an attachment surface.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the priority benefit of the earlier filing dateof U.S. Provisional Patent Application No. 62/166,521, filed May 26,2015, which is specifically incorporated herein by reference in itsentirety.

TECHNICAL FIELD

The present disclosure relates generally to soft tissue repair, and moreparticularly, to systems and methods for fixing soft tissue to anattachment surface.

BACKGROUND

The conventional approach to soft tissue repair includes passingindividual sutures through damaged tissue near the point of intendedfixation. Current techniques require separate passage of the suturematerial each time the suture is passed through the soft tissue to berepaired (e.g., to secure that tissue to a bone or other attachmentsurface). These repairs are complex and time-consuming to perform, andfail frequently.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments will be readily understood by the following detaileddescription in conjunction with the accompanying drawings. To facilitatethis description, like reference numerals designate like structuralelements. Embodiments are illustrated by way of example, and not by wayof limitation, in the figures of the accompanying drawings.

FIGS. 1-3 are various views of a conventional suture arrangement forfixing soft tissue to bone in a typical rotator cuff repair performed inthe shoulder for rotator cuff tear.

FIGS. 4-5 are various views of a helical suture, in accordance withvarious embodiments as it would sit within soft tissue underrepair/reconstruction.

FIGS. 6-8 are various views of a suture arrangement including thehelical suture of FIGS. 4-5 in a rotator cuff repair performed in theshoulder for rotator cuff tear, in accordance with various embodiments.

FIGS. 9-13 are various views of an insertion instrument for providingthe helical suture of FIGS. 4-5 in soft tissue, in accordance withvarious embodiments.

FIGS. 14-19 are various views of another insertion instrument forproviding the helical suture of FIGS. 4-5 in soft tissue, in accordancewith various embodiments.

FIG. 20 illustrates a suture material having a toggle, in accordancewith various embodiments.

FIG. 21 is a cross-sectional view of a helical suture formed from asuture material having a toggle, in accordance with various embodiments.

FIG. 22 is a flow diagram of an illustrative method for fixing softtissue to an attachment surface, in accordance with various embodiments.

FIGS. 23-24 are views of a soft tissue-to-soft tissue repair usinghelical sutures, in accordance with various embodiments.

FIGS. 25-26 are cross-sectional side views of the operation of agripping mechanism of the insertion instrument of FIGS. 14-19, inaccordance with various embodiments.

FIGS. 27-31 are various views of an insertion instrument for providing ahelical suture in soft tissue, in accordance with various embodiments.

FIGS. 32-36 are various views of another insertion instrument forproviding a helical suture in soft tissue, in accordance with variousembodiments.

FIGS. 37A-39 are various views of double helical sutures, in accordancewith various embodiments as would sit within soft tissue.

DETAILED DESCRIPTION

In the following detailed description, reference is made to theaccompanying drawings that form a part hereof wherein like numeralsdesignate like parts throughout, and in which is shown by way ofillustration embodiments that may be practiced. It is to be understoodthat other embodiments may be utilized and structural or logical changesmay be made without departing from the scope of the present disclosure.Therefore, the following detailed description is not to be taken in alimiting sense.

Various operations may be described as multiple discrete actions oroperations in turn, in a manner that is most helpful in understandingthe claimed subject matter. However, the order of description should notbe construed as to imply that these operations are necessarily orderdependent. In particular, these operations may not be performed in theorder of presentation. Operations described may be performed in adifferent order than the described embodiment. Various additionaloperations may be performed and/or described operations may be omittedin additional embodiments.

For the purposes of the present disclosure, the phrase “A and/or B”means (A), (B), or (A and B). For the purposes of the presentdisclosure, the phrase “A, B, and/or C” means (A), (B), (C), (A and B),(A and C), (B and C), or (A, B, and C).

The description uses the phrases “in an embodiment,” or “inembodiments,” which may each refer to one or more of the same ordifferent embodiments. Furthermore, the terms “comprising,” “including,”“having,” and the like, as used with respect to embodiments of thepresent disclosure, are synonymous.

Disclosed herein are methods, systems, and devices that introduce a newway to combat recurrent tissue retraction. Rather than implanting ananchor and passing a preloaded suture by way of individual knot tyingand a multitude of instruments, the inventors have developed methods,systems, and devices that can use a single instrument to pass a suturein such a way that eliminates shearing of the tissue and insteaddistributes the holding forces in both the normal and tangentialdirections.

Embodiments of systems, devices, and methods for fixing soft tissue toan attachment surface are disclosed herein. For example, in someembodiments, soft tissue may be fixed to an attachment surface byproviding one or more helical sutures, such as two helical sutures ofopposite rotation or twist, in the soft tissue. In embodiments, the softtissue has a longitudinal axis along which the soft tissue undergoestension under normal physiological conditions, and the longitudinal axisof the helical suture in the soft tissue is oriented parallel to thelongitudinal axis, or loading axis, of the soft tissue, such that thelongitudinal axis of the helix of the suture is oriented parallel to theline of tension forces.

The systems, devices, and methods disclosed herein may providesignificant advantages over conventional techniques. As noted above,conventional approaches to soft tissue repairs are complex andtime-consuming to perform because each time the suture passes throughthe tissue, a separate maneuver is required. As a result, most suturerepairs/reconstructions in soft tissue are limited to one (simplesuture) or two (mattress suture) passes of the suture through the tissueto be repaired, near the edge of the tissue. These limited points offixation for each suture result in high concentrations of stress in therepaired/reconstructed tissue edge where the suture is passing once ortwice through the tissue. These high stress concentrations lead to ahigh rate of repair/reconstruction failure at the suture-tissueinterface if the soft tissues are exposed to loading under tension.

The systems, devices, and methods disclosed herein provide usefulmedical devices and techniques that may be applied in any type ofsurgical procedure where soft tissue repair or reconstruction undertension is performed, (e.g. orthopedic surgical procedures where tendonsare being repaired to bone, minimally invasive sports medicine, and softtissue repair settings). More generally, the systems and methodsdisclosed herein may be usefully applied in any field or type of surgeryin which soft tissues are to be repaired or reconstructed so thatstresses in the repaired/reconstructed tissues are more widely andevenly distributed than conventionally achievable, resulting indecreased risk of repair/reconstruction failure at the suture-softtissue interface (e.g., via suture cut-out).

The applications of the systems, devices, and methods disclosed hereincould include, but are not limited to, repairs and reconstructions insoft tissue-to-bone, soft tissue-to-soft tissue, softtissue-to-allograft/xenograft material, or soft tissue-to-syntheticmaterial. Thus, the “attachment surfaces” referred to herein may includebone, soft tissue, allograft/xenograft material, synthetic material, anyother suitable material, or a combination thereof. While bone may beused as an illustrative example of an attachment surface, the systemsand methods disclosed herein may be applied to any suitable attachmentsurface.

Disclosed herein is a method for fixing soft tissue of a subject to anattachment surface, for example, bone. In embodiments, the methodincludes providing, and/or inserting, one or more helical suture(s),having a longitudinal axis, in the soft tissue of a subject. Bylongitudinal axis, it is meant herein the axis of the helical suturethat runs down the center of the helix, that is axis which the helixrotate around and/or translates down as it progresses. The soft tissuemay have a longitudinal axis, and/or loading axis and the one or moresutures are oriented with the longitudinal axis of the helical suture inthe soft tissue parallel, or substantially parallel, to the longitudinalaxis of the soft tissue, for example an axis that is undergoingtensional stress. To fix the soft tissue, the helical suture is attachedto the attachment surface, for example by fixing the free end(s) of thehelical suture(s) proximal the attachment surface to the attachmentsurface. The disclosed methods are particularly suited for fixing softtissue that undergoes tension, under normal physiological conditions,along the tissue's longitudinal axis, for example a tendon. In someembodiments, the attachment surface includes bone, such as a humerus. Insome embodiments, the attachment surface includes soft tissue, allograftmaterial, xenograft material, or a synthetic material, or a combinationthereof. In some embodiments, securing the helical suture to theattachment surface includes securing the helical suture to an anchorsecured to, or in, the attachment surface, for example a bone screw orother device implanted or fastened to bone.

In some embodiments, the method includes providing at least two helicalsutures, such as a first helical suture and a second helical suture. Insuch methods, the first and the second helical suture in the soft tissueare provided or inserted such that the longitudinal axis of the secondhelical suture is oriented substantially parallel to the longitudinalaxis of the first helical suture. This second helical suture can besecured to the attachment surface, for example using the same ordifferent anchor secured to the attachment surface. In some embodiments,the first helical suture and the second helical suture have opposite (orthe same) direction of rotation, see, for example, FIGS. 37A-39. Oneadvantage of using two helical sutures with opposite directions ofrotation is that the torque of the sutures is effectively cancelled out.In certain embodiments, the first helical suture and the second helicalsuture overlap, for example when they have opposite directions ofrotation, see, for example, FIG. 39.

In embodiments, providing or inserting a helical suture in soft tissueincludes inserting a helix-shaped needle into the soft tissue, androtating the helix-shaped needle to provide a helical channel in thesoft tissue until the tip of the helix-shaped needle protrudes from thesoft tissue. Suture material is secured to the tip of the helix-shapedneedle, and the direction of rotation of the helix-shaped needle isreversed to retain the helical suture in the soft tissue. In certainembodiments, the helix-shaped needle is plunged into the soft tissue,such as a tendon, and, at full-deployment, the needle tip grasps thefree suture by mechanical means of an eyelet. The helix-shaped needlethen retrogrades the suture to the lateral opening of the tendon in thepath of the helix-shaped needle by reversing the direction of rotationof the helix-shaped needle. In certain embodiments, a secondhelix-shaped needle with the opposite direction of rotation is used toprovide a second helical suture mirroring the first. The two helices mayoverlap one another, creating a double helix. The two helices may bespaced apart, for example at different angles depending on the desireddirection of grip. The process can be repeated as necessary. Inembodiments, the two helical sutures are formed from the same piece ofsuture material. In some embodiment, the helical suture includes between1 and 10 helical turns, such as at least two turns of suture material.

In certain embodiments, providing the helical suture in the soft tissueincludes inserting a helix-shaped needle into the soft tissue, whereinsuture material is secured to the helix-shaped needle, and rotating thehelix-shaped needle to retain the helical suture in the soft tissue. Insuch embodiments, the suture material is pulled with the helix-shapedneedle through the soft tissue.

In embodiments, rotating the helix-shaped needle may include grasping,with a hand of a human operator, an insertion instrument including thehelix-shaped needle, and rotating the insertion instrument with thehand. In embodiments, rotating the helix-shaped needle includes linearlytranslating a slide component of an insertion instrument including thehelix-shaped needle, wherein the linear translation of the slidecomponent causes or results in rotation of the helix-shaped needle. Incertain embodiments, linearly translating the slide component includeslinearly translating a trigger lever away from, or toward, the softtissue. In some embodiments, providing the helical suture in the softtissue includes gripping, with a gripping portion of an insertioninstrument including a helix-shaped needle, the soft tissue, andpulling, with the gripping portion, the soft tissue toward and over thehelix-shaped needle while the helix-shaped needle rotates relative tothe soft tissue and/or the gripping portion of the insertion instrument.In some embodiments of the method, the insertion instrument includes atrigger lever extending perpendicularly from a longitudinal axis of thehelix-shaped needle, where rotating the trigger lever around thelongitudinal axis of the helix-shaped needle causes the gripping portionto grip the soft tissue, and translating the trigger lever along thelongitudinal axis of the helix-shaped needle and away from, or toward,the soft tissue causes the helix-shaped needle to rotate. In someembodiments the insertion instrument is electrically driven. In someembodiments, the helix-shaped needle is included in an insertioninstrument having a rear handle, and the helix-shaped needle does nottranslate with reference to the rear handle when the helix-shaped needleis rotated to provide the helical suture in the soft tissue.

FIGS. 1-3 are various views of a conventional suture arrangement 100 forfixing soft tissue 102 to a bone 180 in a typical rotator cuff repairperformed in the shoulder for rotator cuff tear. In particular, FIG. 1is a side cross-sectional view of the suture arrangement 100, FIG. 2 isa top view of the suture arrangement 100, and FIG. 3 is a frontcross-sectional view of the suture arrangement 100.

In the suture arrangement 100, one or more anchors 106 may be screwedinto or otherwise secured in the bone 180, and one or more sutures 110may be attached to both the soft tissue 102 and the anchor 106 to attachthe soft tissue 102 to the bone 180. The anchor 106 may be, for example,a metal or bio-absorbable anchor. The sutures 110 are typically orientedsubstantially parallel to the axis 108 illustrated in FIGS. 1 and 3. Theaxis 108 is perpendicular to a longitudinal axis 104 of the soft tissue102 (along which is exerted the bulk of the tensive forces experiencedby the soft tissue 102 under normal physiological conditions in whichthe soft tissue 102 is attached to the bone 180). Typically, the anchors106 are preloaded with one or multiple sutures 110. The anchors 106 arean example of a device for “linking” the suture 110 in the soft tissue102 to the bone 180, but any other device for achieving such a purposemay be used.

FIGS. 4 and 5 are various views of a helical suture 400 as it would sitin soft tissue after application, in accordance with various embodimentsdisclosed herein. In particular, FIG. 4 is a perspective view of thehelical suture 400 and FIG. 5 is a side view of the helical suture 400.The helical suture 400 may have a length 402 along the longitudinal axis410 of the helical suture 400. The length 402 may take any suitablevalue. In some embodiments, the length 402 of the helical suture 400 maybe between approximately 10 and approximately 30 millimeters (e.g., +/−2millimeters). For example, the length 402 of the helical suture may beapproximately 20 millimeters (e.g., +/−2 millimeters). The helicalsuture 400 may have a diameter 404, which may take any suitable value,for example for suture material. In some embodiments, the diameter 404of the helical suture 400 may be between approximately 3 andapproximately 8 millimeters (e.g., +/−1 millimeter). For example, thediameter 404 may be approximately 5.5 millimeters (e.g., +/−1millimeter).

The helical suture 400 may be formed of any suitable suture material, ofwhich many conventional examples exist. For example, the suture materialmay be a #2 (0.6 millimeter diameter) braided filament having a solidinner polymer core with a “braided” outer layer. The outer layer isgenerally a much thinner polymer. An appropriate suture material may besmaller or wider than 0.6 millimeters in diameter, and the appropriatesize and material may depend on the type of repair.

The helical suture 400 may have any desired number of turns 406 orfractions thereof (wherein a turn is defined herein as a portion of thecoil traversing 360 degrees, as illustrated by the turn 406 in FIG. 5).In some embodiments, the helical suture 400 may have 1-6 turns orfractional increments thereof, such as about 1, about 2, about 3, about4, about 5, about 6 or, in some cases more than 6 turns. For example,the helical suture 400 may include at least one, at least two, at leastthree, at least four, or at least five turns of suture material.

The helical suture 400 may have any desired turn angle 408 (wherein aturn angle is defined herein with respect to a reference lineperpendicular to the longitudinal axis 410, as illustrated by the turnangle 408 in FIG. 5). In some embodiments, the turn angle 408 may bebetween approximately 20 and approximately 70 degrees (e.g., +/−5degrees). For example, the turn angle 408 may be approximately 45degrees (e.g., +/−5 degrees). The turn angle 408 need not be constantalong the helical suture 400; instead, in some embodiments, the turnangle 408 may vary along the helical suture 400. Additionally, asdiscussed below, the turn angle 408 of the helical suture 400 may changeas the underlying soft tissue 102 undergoes various forces (e.g.,tension, contraction, or movement of the soft tissue). Thus, the turnangle 408 may refer to the turn angle imparted to the helical suture 400when the helical suture 400 is first provided in the soft tissue 102,even though the turn angle 408 may change as the underlying soft tissue102 deforms after provision. The length of suture material required toform a helical suture 400 will depend on the desired geometry of thehelical suture 400, such as the length 402, the diameter 404, the numberof turns 406, and/or the turn angle 408.

Exemplary helical sutures were tested against a massive cuff stitch(which is considered to be one of the strongest traditional stitchconfigurations in rotator cuff tendon tissue). These tests wereperformed in bovine tendon tissue comparing ultimate failure loadsbetween these 2 suture configurations mounted in a uniaxial testingmachine with a 1000 Newton (N) load cell. Testing protocol conformedwith numerous previously published methodologies: Ten Newtons pre-loadfollowed by a stepwise cyclic loading protocol to 180 (N) followed by350 (N) at a rate of 0.25 Hz until complete structure failure occurred(defined as ultimate load). In this biomechanical testing it was foundthat, in terms of gross strength increase (ultimate load), the coil was˜370% stronger (3.7×) than the massive cuff stitch. Average maximum loadof coil was 336.8 N compared to 63.7 N for massive cuff stitch.

The relevant parameters for the helical suture are provided, includingthe total length in suture implanted, the total area enclosed by both,and the ultimate failure load.

Dimensionalities/Variables

-   T=3; number of turns in construct-   D=5; Diameter in millimeters-   H=12; Total height (depth in this case) of construct-   r=2.5; Radius of construct

Equation for Arc Length

Length=2*(T*sqrt((pi*D)̂2+(H/T)̂2))   (2)

Area Enclosed by R-Coil

Area=2*((2*pi*r*H)+(2*pi*r̂2))   (1)

-   Length=97.2556 mm-   Area=455.5309 mm̂2

FIGS. 6-8 are various views of a suture arrangement 600 including thehelical suture 400 of FIGS. 4-5 in a rotator cuff repair performed inthe shoulder for rotator cuff tear, in accordance with variousembodiments. In particular, FIG. 6 is a side cross-sectional view of thesuture arrangement 600, FIG. 7 is a top view of the suture arrangement600, and FIG. 8 is a front cross-sectional view of the suturearrangement 600.

In the suture arrangement 600, one or more anchors 106 may be screwedinto or otherwise secured in the bone 180 (as discussed above withreference to the suture arrangement 100 of FIGS. 1-3). This scenariooutlines the method for rotator cuff repair (an example clinicalapplication), in which one or more anchors 106 may be implanted into themedial edge of the tendon footprint on the lateral aspect of the humeralhead. One or more helical sutures 400 may be attached to both the softtissue 102 and the anchor 106 to attach the soft tissue 102 to the bone180. In particular, a helical suture 400 may be oriented in the softtissue 102 such that the longitudinal axis 410 (FIG. 4) of the helicalsuture 400 is oriented parallel to the longitudinal axis 104 of the softtissue 102. Thus, unlike the conventional suture 110 of FIGS. 1-3, inwhich the soft tissue 102 is fixed by the suture 110 at only one or twosmall, finite points, the bulk of the suture material of the helicalsuture 400 is distributed along the longitudinal axis 104 of the softtissue 102 (in the direction in which tension is typically experiencedby the soft tissue 102 under normal physiological conditions).

As shown in FIGS. 7 and 8, the suture arrangement 600 may include morethan one helical suture 400 (e.g., the two sutures 400 illustrated inFIGS. 7 and 8). In other embodiments, a single helical suture 400 may beused, or two or more helical sutures 400, such as three or more, may beused. All of the helical sutures 400 included in a multiple helicalsuture arrangement may be oriented substantially in parallel (e.g.,having their longitudinal axes 410 substantially parallel to thelongitudinal axis 104 of the soft tissue 102) or may be oriented at anydesired orientation with respect to each other. As discussed latter,with respect to FIGS. 37A-39, a single strand of suture material can beused to form two or more helical sutures. For example having the same oropposite helical rotations.

In some embodiments, the soft tissue 102 may be a tendon. In someembodiments, the bone 108 may be a humerus. Other examples of softtissue repair to bone in which the systems and methods disclosed hereincould be applied may include, but are not limited to, quadraceps andpatella tendon repairs to the patella (knee cap), Achilles tendonrepair, bicep tenodesis repair, pectoralis major tendon repairs to thehumerus; and ligament repairs including, but not limited to, repair ofthe lateral ulnar collateral ligament at the elbow/distal humerus. Anymid-substance soft tissue rupture such as mid-substance ligament tears,or mid-substance tendon tears are also amenable to systems and methodsin which helical suture configurations (e.g., arrangements including oneor more helical suture 400) are placed into both sides of the tear, andrepair of the defect is achieved by tightening and tying together thefree ends of the sutures from each side of the tear. Non-tendon orligament examples of surgical application include abdominal herniarepairs.

As illustrated in FIGS. 6-8, the helical suture 400 provides multipleloops of suture material through the soft tissue 102, with the primarydistribution pattern of the suture material through the soft tissue 102oriented in a helix running parallel to the primary direction oftension/loading in the soft tissue 102. The helical suture 400, whenused in this manner, may distribute stress more broadly and evenlythrough the soft tissue 102 than the conventional sutures 110 discussedabove with reference to FIGS. 1-3. This may reduce the likelihood ofrepair failures that can occur using conventional approaches, forexample due to tension overload at the suture-tissue interface (leadingto the suture cutting through the repaired tissue).

In particular, conventional sutures (e.g., using a simple stitch, amattress stitch, a modified Mason-Allen stitch, or a massive cuffstitch) employ single-point fixation for each suture. Such sutures passthrough soft tissue as few as one time, or a maximum of four times, allperformed in a small area where the tendon is “spot welded” to theattachment surface. As these repairs are exposed to stress (inparticular, tension) after surgery, the suture often cuts through thetendon in a similar manner as cheese wire cuts through a block ofcheese. The result is the loss of tendon fixation and failure of therepair because stresses within the tissue are focused over too small anarea of tissue, confined to the lateral edge of the tendon directly overthe site of tendon-to-bone fixation. It is suggested that even whencomplete repair failure does not occur after rotator cuff repairsurgery, the majority of conventional repairs at least partially fail(in that the suture slips at least partially through the tendon). Bothpartial and complete repair failures result in persistent pain anddisability for patients and/or the need for further surgicalintervention. Additionally, passing conventional sutures through softtissue and tying them to hold the tissue to its attachment point arecomplex and time-consuming procedures that are not always executedsuccessfully.

Use of the helical sutures 400 disclosed herein may reduce the incidenceof repair failures after soft tissue repair surgeries (e.g., rotatorcuff repair) by reducing the incidence of suture cut-through of the softtissue. Various embodiments of the helical sutures disclosed herein mayprovide a broader (e.g., spread out) and more even distribution ofstress within the repaired tissue in one or more ways. For example, thehelical suture 400 may present a greatly increased number of points ofsuture-soft tissue interface relative to conventional sutures,distributing forces more broadly in the soft tissue. By positioning thehelical suture 400 so that it extends medially into the soft tissue,forces experienced by the helical suture 400 may be distributed anddissipated by the medial tissue, rather than being entirely concentratedin the most lateral portion of the tissue being repaired (theconventional result). Additionally, when the soft tissue undergoesdeformation due to tension forces and the helical suture 400 “lengthens”as a result, the helical suture 400 directs the tension forces bothnormally (into the tissue “inside” the helical suture 400 to compressthat tissue) and tangentially (in the directions tangent to the helicalsuture 400). This distribution of forces may improve the “grip” of thehelical suture 400 on the soft tissue when the soft tissue undergoestension, reducing the likelihood of repair failure.

Additionally, use of various ones of the helical sutures 400 disclosedherein may eliminate or reduce the need for tying or significant suturemanagement during surgery, as well as provide a significantly strongerrepair construct than conventionally achievable.

The helical suture 400 may be provided to the soft tissue 102 using anysuitable technique. For example, the helical suture 400 may be providedto the soft tissue 102 using a full open or minimally invasive (e.g.,arthroscopic or laparoscopic) surgical technique. For example, a rotatorcuff repair may be performed through a 4-10 centimeter skin incision orarthroscopically through 4-8 small 0.5 centimeter skin incisions. Arotator cuff repair may include two suture anchors and accompanyinghelical sutures 400, although more may be implanted when the quality ofthe soft tissue 102 is poor, or the tear is larger.

In some embodiments, the helical suture 400 may be provided to the softtissue 102 using an insertion instrument designed for the rapid andaccurate provision of the helical suture 400. For example, FIGS. 9-13are various views of an insertion instrument 900 for providing thehelical suture 400 in the soft tissue 102, in accordance with variousembodiments (FIGS. 27-39, discussed below are various views of analternative insertion instrument for providing the helical suture in thesoft tissue, in accordance with various embodiments). In particular,FIG. 9 is a perspective view of the insertion instrument 900, FIG. 10 isa detailed view of the helix-shaped needle 902 (as indicated by circle Aof FIG. 9), FIG. 11 is a side view of the insertion instrument 900, FIG.12 is a detailed side view of the helix-shaped needle 902 (as indicatedby circle B of FIG. 11), and FIG. 13 is a detailed side view of the end914 of the helix-shaped needle 902 (as indicated by circle C of FIG.12).

The insertion instrument 900 may have an extended body 924 thatsubstantially defines the longitudinal axis 908 of the insertioninstrument 900. The insertion instrument 900 may be formed of one ormore materials, such as plastics and/or metals (e.g., medical gradetitanium or aluminum). The insertion instrument 900 may also include ahelix-shaped needle 902 at one end 922 of the body 924. The helix-shapedneedle 902 may have a longitudinal axis 920 that is parallel with (e.g.,coextensive with) the longitudinal axis 908 of the insertion instrument900. The helix-shaped needle 902 may have a cutting tip for cutting intosoft tissue, or the helix-shaped needle 902 may be loaded with a suturematerial having a toggle with a cutting tip, as discussed below withreference to FIGS. 20-21.

The body 924 of the insertion instrument 900 may have a length 906,which may be any suitable value. In some embodiments, the length 906 maybe between approximately 100 and approximately 180 millimeters (e.g.,+/−10 millimeters). For example, the length 906 may be approximately 140millimeters (e.g., +/−10 millimeters).

Since the dimensions of the helix-shaped needle 902 substantiallydetermine the dimensions of the helical suture 400 provided by use ofthe insertion instrument 900 (as discussed below), the dimensions of thehelix-shaped needle 902 may be selected to achieve desired dimensions ofthe helical suture 400. For example, the helix-shaped needle 902 mayhave a length 910, which may be any suitable value. In some embodiments,the length 910 may be between approximately 10 and approximately 30millimeters (e.g., +/−2 millimeters). For example, the length 910 may beapproximately 20 millimeters (e.g., +/−2 millimeters). The helix-shapedneedle 902 may have a diameter 912, which may be any suitable value. Forexample, in some embodiments, the diameter 912 may be betweenapproximately 3 and approximately 8 millimeters (e.g., +/−1 millimeter).In some embodiments, the diameter 912 may be approximately 5.5millimeters (e.g., +/−1 millimeter).

Suture material may be secured to the helix-shaped needle 902 such that,as the helix-shaped needle 902 is moved through the soft tissue 102, thesuture material follows the path of the helix-shaped needle 902 to formthe helical suture 400. As shown in FIGS. 10, 12, and 13, thehelix-shaped needle 902 may have a recess 904 in which suture material(not shown) may be disposed. The dimensions of the recess 904 may beselected based on the properties of the soft tissue through which thehelix-shaped needle 902 is to pass and/or the dimensions of the suturematerial to be disposed inside the recess 904. In some embodiments, aninner radius 936 of the recess 904 may be between approximately 0.1 andapproximately 0.4 millimeters (e.g., +/−0.03 millimeters). For example,the inner radius 936 may be approximately 0.26 millimeters (e.g.,+/−0.03 millimeters). An outer radius 918 of the helix-shaped needle 902may be selected based on the properties of the soft tissue through whichthe helix-shaped needle 902 is to pass, the dimensions of the suturematerial to be disposed inside the recess 904, and/or the property ofthe material forming the helix-shaped needle 902 (e.g., with thicker“walls” appropriate for weaker materials). In some embodiments, theouter radius 918 of the helix-shaped needle 902 may be betweenapproximately 0.2 and approximately 0.4 millimeters (e.g., +/−0.03millimeters). For example, the outer radius 918 of the helix-shapedneedle 902 may be approximately 0.3 millimeters (e.g., +/−0.03millimeters). In another example, a helix-shaped needle 902 with aninner radius of approximately 0.3 millimeters and an outer radius ofapproximately 0.35 millimeters may be appropriate to contain a #2 suturematerial.

An end 914 of the helix-shaped needle 902 may have an opening 916 intowhich suture material may be inserted and retained within the recess 904during use of the insertion instrument 900 to form the helical suture400 with the suture material. As discussed below with reference to FIGS.20 and 21, the suture material may have a tip that may serve as a tip ofthe helix-shaped needle 902 when the suture material is disposed in therecess 904 of the insertion instrument 900. The tip of the suturematerial may also serve as a toggle to hold the helical suture 400 inplace in the soft tissue 102 after the helical suture 400 has beenformed and the insertion instrument 900 has been removed.

The insertion instrument 900 may be used to provide a helical suture 400to the soft tissue 102 by having a human operator grasp the body 924with her hand, insert the helix-shaped needle 902 into the soft tissue102 (with suture material secured to the helix-shaped needle 902), androtate the helix-shaped needle 902 to move the helix-shaped needle 902and the suture material through the soft tissue 102 to form the helicalsuture 400. When insertion is complete, an end of the suture materialproximate to the end 914 of the helix-shaped needle 902 may be securedwithin or external to the soft tissue 102 (e.g., by grasping the endwith an arthroscopic suture grasper, or as discussed below withreference to FIGS. 20 and 21) and the insertion instrument 900 may beremoved by rotating the insertion instrument 900 in the reversedirection, leaving the helical suture 400 behind. Removal of theinsertion instrument 900 from the soft tissue 102 may also pull thehelical suture 400 “taut,” providing a uniform and correct amount oftension in each turn of the helical suture 400. In some examples, thesuture is pulled taught by the human operator, for example by applying aload to the suture material that extends from the soft tissue, forexample a load of about 5 N to about 20 N, such that the helical sutureis tightened in the tissue. A tensiometer can be used to measure thetension, such that this is not over-applied, for example a tensiometerthat provides a visual or audible indication of proper tension. Such atensiometer could be coupled to any of the devices disclosed herein.

FIGS. 27-31, are various views of an alternative insertion instrument2700 for providing the helical suture 400 in the soft tissue 102, inaccordance with various embodiments. FIG. 27 is a side view of theinsertion instrument 2700, FIG. 28 is a detailed side view of thehelix-shaped needle 2702 (as indicated by circle B of FIG. 27), andFIGS. 29-31 are detailed perspective views of the end 2714 of thehelix-shaped needle 2702 (as indicated by circle C of FIG. 28). Asdiscussed below, a difference between the insertion instrument 900 andthe insertion instrument 2700 is how the suture is passed through thetissue.

The insertion instrument 2700 may have an extended body 2724 thatsubstantially defines the longitudinal axis 2708 of the insertioninstrument 2700. The insertion instrument 2700 may be formed of one ormore materials, such as plastics and/or metals (e.g., medical gradetitanium or aluminum). The insertion instrument 2700 may also include ahelix-shaped needle 2702 at one end of the body 2706 connected by bend2726. The helix-shaped needle 2702 may have a longitudinal axis that isparallel with (e.g., coextensive with) the longitudinal axis 2708 of theinsertion instrument 2700. The helix-shaped needle 2702 may have acutting tip 2750 for cutting into soft tissue.

The body 2724 of the insertion instrument 2700 may have a length 2706,which may be any suitable value. In some embodiments, the length 2706may be between approximately 100 and approximately 180 millimeters(e.g., +/−10 millimeters). For example, the length 2706 may beapproximately 140 millimeters (e.g., +/−10 millimeters).

Since the dimensions of the helix-shaped needle 2702 substantiallydetermine the dimensions of the helical suture 400 provided by use ofthe insertion instrument 2700 (as discussed below), the dimensions ofthe helix-shaped needle 2702 may be selected to achieve desireddimensions of the helical suture 400. For example, the helix-shapedneedle 2702 may have a length 2710, which may be any suitable value. Insome embodiments, the length 2710 may be between approximately 10 andapproximately 30 millimeters (e.g., +/−2 millimeters). For example, thelength 2710 may be approximately 20 millimeters (e.g., +/−2millimeters). The helix-shaped needle 2702 may have a diameter 2712,which may be any suitable value. For example, in some embodiments, thediameter 2712 may be between approximately 3 and approximately 8millimeters (e.g., +/−1 millimeter). In some embodiments, the diameter2712 may be approximately 5.5 millimeters (e.g., +/−1 millimeter).

As the helix-shaped needle 2702 is moved through the soft tissue 102, achannel is formed in the soft tissue 102. Once the cutting tip 2750pierces the outer surface of the soft tissue 102, suitable suturematerial is coupled to the cutting tip 2750 in recess 2760 by looping,or otherwise securing the suture material over hook 2764. As thehelical-shaped needle 2702 is backed out of the soft tissue 102, thesuture material follows the path of the helix-shaped needle 2702 in thechannel to form the helical suture 400. As shown in FIGS. 29-31, thehelix-shaped needle 2702 may have a recess 2760 in which suture material(not shown) may be disposed. The dimensions of the recess 2760 may beselected based on the properties and/or the dimensions of the suturematerial to be disposed inside the recess 2760. In some embodiments, thedepth of the recess 2760 may be between approximately 0.1 andapproximately 0.4 millimeters (e.g., +/−0.03 millimeters). An outerradius of the helix-shaped needle 2702 may be selected based on theproperties of the soft tissue through which the helix-shaped needle 2702is to pass, the dimensions of the suture material to be disposed insidethe recess 2760, and/or the property of the material forming thehelix-shaped needle 2702. In some embodiments, the outer radius of thehelix-shaped needle 2702 may be between approximately 0.2 andapproximately 0.4 millimeters (e.g., +/−0.03 millimeters). For example,the outer radius of the helix-shaped needle 2702 may be approximately0.3 millimeters (e.g., +/−0.03 millimeters). The recess 2760 preferablyhas a hook like structure 2764 to grasp or hold the suture material.

The cutting tip 2750 of the helix-shaped needle 2702 may have anysuitable cutting shape, although a shape with two planes 2751 and 2752is shown bisected by a cutting ridge 2754.

The insertion instrument 2700 may be used to provide a helical suture400 to the soft tissue 102 by having a human operator grasp the body2724 with her hand, insert the helix-shaped needle 2702 into the softtissue 102 (with suture material secured to the helix-shaped needle902), and rotate the helix-shaped needle 2702 to move the helix-shapedneedle 2702 through the soft tissue 102 to form the helical suture 400.When insertion is complete, the cutting tip 2750 protruding through thesoft tissue 102 secures suitable suture material with hook 2764 ofrecess 2760, and the insertion instrument 2700 may be removed byrotating the insertion instrument 2700 in the reverse direction, leavingthe helical suture 400 behind. Removal of the insertion instrument 900from the soft tissue 102 may also pull the helical suture 400 “taut,”providing a uniform and correct amount of tension in each turn of thehelical suture 400. In some examples, the suture is pulled taught by thehuman operator, for example by applying a load to the suture materialthat extends from the soft tissue, for example a load of about 5 N toabout 20 N, such that the helical suture is tightened in the tissue. Atensiometer can be used to measure the tension, such that this is notover-applied, for example a tensiometer that provides a visual oraudible indication of proper tension. Such a tensiometer could becoupled to any of the devices disclosed herein.

FIGS. 14-19 are various views of another insertion instrument 1400 forproviding the helical suture 400 in the soft tissue 102, in accordancewith various embodiments. In particular, FIG. 14 is a sidecross-sectional view of the insertion instrument 1400, FIG. 15 is adetailed side cross-sectional view of a portion of a needle assembly1430 in the needle chamber 1416 of the insertion instrument 1400, FIG.16 is a side view of the insertion instrument 1400, FIG. 17 is a topview of the insertion instrument 1400, FIG. 18 is a front view of theinsertion instrument 1400, and FIG. 19 is a rear view of the insertioninstrument 1400.

The insertion instrument 1400 may include a needle assembly 1430 thatmay take the form of any suitable ones of the embodiments discussedabove with reference to the insertion instrument 900 (FIGS. 9-13) orinsertion instrument 2700. In particular, the needle assembly 1430 mayinclude a body 1406 (which may take the form of any suitable ones of theembodiments of the body 924) and a helix-shaped needle 1408 (which maytake the form of any suitable ones of the embodiments of thehelix-shaped needle 902 or 2702). The needle assembly 1430 may bedisposed partially within a needle chamber 1416 and partially within aslide component 1410 (e.g., as illustrated in FIGS. 14 and 15). Inparticular, the helix-shaped needle 1408 may have a longitudinal axis1460 defined analogously as discussed above with reference to thelongitudinal axis 920 of the helix-shaped needle 902 of the insertioninstrument 900 (FIG. 9) or 2720 of the helix-shaped needle 2702 of theinsertion instrument 2700 (FIG. 27).

The slide component 1410 of the insertion instrument 1400 may beconfigured to cause the needle assembly 1430 to rotate upon lineartranslation of the slide component 1410 in the direction indicated bythe arrow 1450. In particular, the slide component 1410 may house ahelical bearing, a portion of the body 1406 of the needle assembly 1430,and rifled sidewalls that articulate with the helical bearing as theslide component 1410 translates in the direction indicated by the arrow1450 to cause rotation of the needle assembly 1430. The slide component1410 may be coupled to a trigger lever 1404 such that, as the triggerlever 1404 moves toward a rear handle 1402 (e.g., in the directionindicated by the arrow 1450) and away from the soft tissue 102 (notshown, but positioned proximate to the helix-shaped needle 1408), theslide component 1410 also translates in the direction indicated by thearrow 1450, causing the needle assembly 1430 to rotate, the oppositemotion causes it to rotate the other direction and could be used for ahelix-shaped needle having an opposite direction of rotation. Thedirection of rotation of the needle assembly 1430 upon translation ofthe slide component 1410 is such that the helix-shaped needle 1408 isdriven into the soft tissue 102 when the insertion instrument 1400 isappropriately applied to the soft tissue 102. The trigger lever 1404 maybe biased away from movement toward the rear handle 1402 by a recoilspring in the recoil spring chamber 1428. The recoil spring may have anysuitable spring constant, such as approximately 590 Newtons/meter (e.g.,+/−20 Newtons/meter).

The insertion instrument 1400 may include a gripping portion 1414. Thegripping portion 1414 may be coupled to a grip articulator 1412, whichmay be in turn coupled to the trigger lever 1404 via a channel 1480. Thetrigger lever 1404, the grip articulator 1412, and the gripping portion1414 may be arranged such that the trigger lever 1404 extendsperpendicularly from the longitudinal axis 1460 of the helix-shapedneedle 902 or 2702 and rotating the trigger lever 1404 around thelongitudinal axis 1460 causes the gripping portion 1414 to close on andgrip the soft tissue 102 disposed against the needle chamber 1416. Inparticular, rotation of the trigger lever 1404 forces concentricmovement by means of the channel 1480, causing pushrods of the grippingportion 1414 to open and close teeth of the gripping portion 1414. A“tooth” with a fixed position on the inside of the trigger lever 1404acts as a male piece to the channel 1480. Because the trigger lever 1404and thus the tooth is fixed in relation to the longitudinal axis 1460,but the grip articulator 1412 is not (having some amount of play, e.g.,approximately 10 millimeters), as the trigger lever 1404 is rotatedperpendicular to the longitudinal axis 1460, the tooth exerts force uponthe walls of the channel 1480. Because the tooth is not fixed along thelongitudinal axis 1460, the tooth will slide forward or backwarddepending on the direction of rotation of the trigger lever 1404. Thisopens or closes gripping teeth of the gripping portion 1414 as a distalend of the grip articulator 1412 is fixed on a planar side of a grippingtooth. As discussed below with reference to FIGS. 25 and 26, a proximalend of a gripping tooth is fixed onto the needle chamber 1416 with across pin, acting as an axis of rotation without translation. As a pushrod of the grip articular 1412 extends out, the push rod exerts forceonto the midpoint of the gripping tooth, which creates rotation aboutthe fixed axis. FIG. 18 depicts the trigger lever 1404 after a smallrotation around the longitudinal axis 1460, and an embodiment of thegripping mechanism is discussed in further detail below with referenceto FIGS. 25-26.

Once the soft tissue 102 has been gripped by the gripping portion 1414,translating the trigger lever 1404 along the longitudinal axis 1460 awayfrom the soft tissue 102 (e.g., in the direction indicated by the arrow1450) may cause the helix-shaped needle 1408 to rotate while thegripping portion 1414 is also caused to pull the soft tissue 102 in thedirection indicated by the arrow 1450. The result of these substantiallysimultaneous operations is the rotation of the helix-shaped needle 1408into the soft tissue 102 as the soft tissue 102 is pulled onto and alongthe helix-shaped needle 1408. In some embodiments, the helix-shapedneedle 1408 may not translate with reference to the rear handle 1402during use of the insertion instrument 1400 to provide a helical suture400 to the soft tissue 102. Instead, the gripping portion 1414 may causethe soft tissue 102 to be pulled toward the rear handle 1402 while thehelix-shaped needle 1408 rotates but does not translate. In otherembodiments (not shown), the helix-shaped needle 1408 may translate inthe direction opposite to the arrow 1450 and rotate to provide thehelical suture 400 to the soft tissue 102 while the gripping portion1414 may not translate with reference to the rear handle 1402.

The insertion instrument 1400 may be used to provide a helical suture400 to the soft tissue 102 by having a human operator grasp the rearhandle 1402 and the trigger lever 1404, position the needle chamber 1416against the soft tissue 102, rotate the trigger lever 1404 around thelongitudinal axis 1460 of the helix-shaped needle 1408 to cause thegripping portion 1414 to grip the soft tissue 102, squeeze the triggerlever 1404 towards the rear handle 1402 (against the spring forceprovided by the recoil spring in the recoil spring chamber 1428) tocause the gripping portion 1414 to pull the soft tissue 102 over thehelix-shaped needle 1408 and simultaneously cause the helix-shapedneedle 1408 to rotate into the soft tissue 102 (thereby moving suturematerial coupled to the helix-shaped needle 1408 through the soft tissue102 to form the helical suture 400). When insertion is complete, an endof the suture material proximate to the distal end of the helix-shapedneedle 1408 may be secured within or external to the soft tissue 102(e.g., by grasping the end with an arthroscopic suture grabber, or asdiscussed below with reference to FIGS. 20 and 21) and the insertioninstrument 1400 may be removed by reversing the operations discussedabove. Removal of the insertion instrument 1400 from the soft tissue 102may also pull the helical suture 400 “taut,” providing an even andcorrect amount of tension in each turn of the helical suture 400. Insome examples, the suture is pulled taught by the human operator, forexample by applying a load to the suture material that extends from thesoft tissue, for example a load of about 5 N to about 20 N, such thatthe helical suture is tightened in the tissue. A tensiometer can be usedto measure the tension, such that this is not over-applied, for examplea tensiometer that provides a visual or audible indication of propertension. Such a tensiometer could be coupled to any of the devicesdisclosed herein.

FIGS. 32-36 are various views of another insertion instrument 3200 forproviding the helical suture 400 in the soft tissue 102, in accordancewith various embodiments. In particular, FIGS. 32 and 33 are perspectiveviews of the insertion instrument 3200 is a side cross-sectional view ofthe insertion instrument 3200. FIGS. 35 and 36 are perspective views ofa portion of the slide element of the insertion instrument 3200. FIG. 36is a side cross-sectional view of the insertion instrument 1400.

The insertion instrument 3200 may include a needle assembly 3230 thatmay take the form of any suitable ones of the embodiments discussedabove with reference to the insertion instrument 900 (FIG. 9-13) or 2700(FIGS. 27-31). In particular, the needle assembly 3230 may include abody 3206 (which may take the form of any suitable ones of theembodiments of the body 924 or 2724) and a helix-shaped needle 3208(which may take the form of any suitable ones of the embodiments of thehelix-shaped needle 902, or 2702). The needle assembly 3230 may bedisposed partially within a needle chamber 3216 and partially within aslide component 3210 (e.g., as illustrated in FIG. 32). In particular,the helix-shaped needle 3208 may have a longitudinal axis 3260 definedanalogously as discussed above with reference to the longitudinal axis920 of the helix-shaped needle 902 of the insertion instrument 900 (FIG.9) or the longitudinal axis 2720 of the helix-shaped needle 2702 of theinsertion instrument 2700 (FIG. 27).

The slide component 3210 of the insertion instrument 3200 may beconfigured to cause the needle assembly 3230 to rotate upon lineartranslation of the slide component 3210 in the direction indicated bythe arrow 3250. In particular, the slide component 3210 may house ahelical bearing, a portion of the body 3206 of the needle assembly 3230,and rifled sidewalls that articulate with the helical bearing 3220 asthe slide component 3210 translates in the direction indicated by thearrow 3250 to cause rotation of the needle assembly 3230. The slidecomponent 3210 may be coupled to a trigger lever 3204 such that, as thetrigger lever 3204 moves toward a rear handle 3202 (e.g., in thedirection indicated by the arrow 3250) and away from the soft tissue 102(not shown, but positioned proximate to the helix-shaped needle 3208),the slide component 3210 also translates in the direction indicated bythe arrow 3250, causing the needle assembly 3230 to rotate, the oppositemotion causes it to rotate the other direction and could be used for ahelix-shaped needle having an opposite direction of rotation. Thedirection of rotation of the needle assembly 3230 upon translation ofthe slide component 3210 is such that the helix-shaped needle 3208 isdriven into the soft tissue 102 when the insertion instrument 3200 isappropriately applied to the soft tissue 102. The trigger lever 3204 maybe biased away from movement toward the rear handle 3202 by a recoilspring in the recoil spring chamber 3228. The recoil spring may have anysuitable spring constant, such as approximately 590 Newtons/meter (e.g.,+/−20 Newtons/meter).

The insertion instrument 3200 may include a gripping portion 3214. Thegripping portion 3214 may be coupled to a grip articulator 3212, whichmay be in turn coupled to the trigger lever 3204 via a channel 3280. Thetrigger lever 3204, the grip articulator 3212, and the gripping portion3214 may be arranged such that the trigger lever 3204 extendsperpendicularly from the longitudinal axis 3260 of the helix-shapedneedle 902 and rotating the trigger lever 3204 around the longitudinalaxis 3260 causes the gripping portion 3214 to close on and grip the softtissue 102 disposed against the needle chamber 3216. In particular,rotation of the trigger lever 3204 forces concentric movement by meansof the channel 3280, causing pushrods of the gripping portion 3214 toopen and close teeth of the gripping portion 3214. A “tooth” with afixed position on the inside of the trigger lever 3204 acts as a malepiece to the channel 3280. Because the trigger lever 3204 and thus thetooth is fixed in relation to the longitudinal axis 3260, but the griparticulator 3212 is not (having some amount of play, e.g., approximately10 millimeters), as the trigger lever 3204 is rotated perpendicular tothe longitudinal axis 3260, the tooth exerts force upon the walls of thechannel 3280. Because the tooth is not fixed along the longitudinal axis3260, the tooth will slide forward or backward depending on thedirection of rotation of the trigger lever 3204. This opens or closesgripping teeth of the gripping portion 3214 as a distal end of the griparticulator 3212 is fixed on a planar side of a gripping tooth. Asdiscussed below with reference to FIGS. 25 and 26, a proximal end of agripping tooth is fixed onto the needle chamber 3216 with a cross pin,acting as an axis of rotation without translation. As a push rod of thegrip articular 3212 extends out, the push rod exerts force onto themidpoint of the gripping tooth, which creates rotation about the fixedaxis. FIG. 18 depicts the trigger lever 3204 after a small rotationaround the longitudinal axis 3260.

Once the soft tissue 102 has been gripped by the gripping portion 3214,translating the trigger lever 3204 along the longitudinal axis 3260 awayfrom the soft tissue 102 (e.g., in the direction indicated by the arrow3250) may cause the helix-shaped needle 3208 to rotate while thegripping portion 3214 is also caused to pull the soft tissue 102 in thedirection indicated by the arrow 3250. The result of these substantiallysimultaneous operations is the rotation of the helix-shaped needle 3208into the soft tissue 102 as the soft tissue 102 is pulled onto and alongthe helix-shaped needle 3208. In some embodiments, the helix-shapedneedle 3208 may not translate with reference to the rear handle 3202during use of the insertion instrument 3200 to provide a helical suture400 to the soft tissue 102. Instead, the gripping portion 3214 may causethe soft tissue 102 to be pulled toward the rear handle 3202 while thehelix-shaped needle 3208 rotates but does not translate. In otherembodiments (see FIGS. 33 and 34), the helix-shaped needle 3208 maytranslate in the direction opposite to the arrow 3250 and rotate toprovide the helical suture 400 to the soft tissue 102 while the grippingportion 3214 may not translate with reference to the rear handle 3202.

The insertion instrument 3200 may be used to provide a helical suture400 to the soft tissue 102 by having a human operator grasp the rearhandle 3202 and the trigger lever 3204, position the needle chamber 3216against the soft tissue 102, rotate the trigger lever 3204 around thelongitudinal axis 3260 of the helix-shaped needle 3208 to cause thegripping portion 3214 to grip the soft tissue 102, squeeze the triggerlever 3204 towards the rear handle 3202 (against the spring forceprovided by the recoil spring in the recoil spring chamber 3228) tocause the gripping portion 3214 to pull the soft tissue 102 over thehelix-shaped needle 3208 and simultaneously cause the helix-shapedneedle 3208 to rotate into the soft tissue 102 (thereby moving suturematerial coupled to the helix-shaped needle 3208 through the soft tissue102 to form the helical suture 400). Removal of the insertion instrument3200 from the soft tissue 102 may also pull the helical suture 400“taut,” providing an even and correct amount of tension in each turn ofthe helical suture 400.

Use of the insertion instruments disclosed herein (e.g., the insertioninstrument 900 or 2700 or the insertion instrument 1400 or 3200) mayenable the provision of the helical suture 400 to the soft tissue 102with speed and accuracy. For example, use of the insertion instrument1400 or 2700 may enable an operator to perform one motion to causemultiple turns of the helical suture 400 to be formed.

In some embodiments, the insertion instrument 1400 or the insertioninstrument 3200 may make an audible “click” or other sound as thehelical suture 400 is formed to indicate when a turn has been completed.The purpose of the “audible click” is to provide tactile and auralfeedback as to the position of the coil in visually diminishedcircumstances (e.g., when a surgeon cannot see the state of needledeployment). Each click would essentially indicate one full turn ofsuture loop and thus a predetermined amount of suture depth (e.g., basedon the turn angle). The mechanical feature creating the audible clickmay include a series of notches along the longitudinal axis 1460 or thelongitudinal axis 3260 within the recoil spring chamber 1428 or therecoil spring chamber 3228 over which an opposing notch on the triggerlever 1404 the trigger lever 3204 would “trip” as it is engaged alongthe longitudinal axis 1460 or the longitudinal axis 3260.

During use, the needle assembly 1430 or 3230 may come sterilely packagedand preloaded with suture material. The packaging may be loadedintra-operatively and loaded into the needle chamber 1416 of theinsertion instrument 1400 or 3216 of the insertion instrument 3200.After the insertion instrument 1400, or 3200 has been used to form ahelical suture 400, the needle assembly 1430 or 3230 may be disposed ofand the remainder of the insertion instrument 1400 or 3200 may bereloaded with another needle assembly 1430 or 3230 to form anotherhelical suture 400, or the remainder of the insertion instrument 1400 or3200 may be cleaned (e.g., autoclaved) for another procedure. In thismanner, the remainder of the insertion instrument 1400 or 3200 may bereusable and kept as a permanent instrument. In some examples, theneedle assembly 1430 or 3230 can be used multiple times within the samesurgical procedure. In some examples, the insertion instrument 900and/or 2700 may be a single suture passage device. In some examples theinsertion instrument 900 and/or 2700 is/are intended for multiple suturepassages. One needle used per surgery, but can be used as many times asdesired during that surgical procedure.

The embodiment of the helical suture 400 illustrated in FIGS. 6-8 isdepicted as having two “free” ends of suture material at either end ofthe helical suture 400. These free ends may be knotted or otherwisesecured to prevent the helical suture 400 from coming undone as thehelical suture 400 undergoes force. In other embodiments of the helicalsuture 400, the helical suture 400 may have a toggle at one end thatserves to “lock” one end of the helical suture 400 on the outside of thesoft tissue 102 and prevent that end of the helical suture 400 fromretreating into the soft tissue 102.

FIG. 20 illustrates a suture material 2000 having a toggle 2004, inaccordance with various embodiments. The toggle 2004 may be permanentlyattached to one end of the suture body 2002. The suture body 2002 may beformed of any suitable suture material, as discussed above. The toggle2004 may also be formed from any suitable material that will not undergodeformation or failure when the helical suture 400 experiences normalphysiological forces. Examples of materials that may be used in variousembodiments include plastics and metals, such as a medical gradetungsten or aluminum, tantalum alloy, polyetheretherketone (PEEK), andbiodegradable and non-biodegradable synthetics such as reaction polymersand bioplastics. In some embodiments, the toggle 2004 may be a tungstenarc tip permanently attached to the end of the suture body 2002.

The toggle 2004, when loaded into an insertion instrument (e.g., theinsertion instrument 900 or the insertion instrument 1400) may serve asthe tip of a helix-shaped needle (e.g., the helix-shaped needle 902 orthe helix-shaped needle 1408). In particular, the suture body 2002 maybe loaded into a recess in the helix-shaped needle (e.g., the recess904) and the toggle 2004 may sit at the distal end of the helix-shapedneedle (e.g., the end 914). In some embodiments, the toggle 2004 may bedimensioned to have a base that has approximately the same outerdimensions as the outer dimensions of the end of the helix-shaped needle(e.g., the same outer radius 918 of the end 914 of the helix-shapedneedle 902).

The suture body 2002 may be coupled to the toggle 2004 in a manner thatallows the toggle 2004 to rotate relative to the suture body 2002.Illustration (A) of FIG. 20 depicts the toggle 2004 in a “needle tip”orientation (e.g., the orientation of the suture material 2000 when thesuture material 2000 is loaded into an insertion instrument) whileillustration (B) of FIG. 20 depicts a toggle 2004 in a rotated “locked”orientation (e.g., the orientation of the suture material 2000 when thesuture material 2000 has been used to form a helical suture 400 and thetoggle 2004 is positioned at an outer surface of the soft tissue 102).FIG. 21 is a cross-sectional view of a helical suture 400 (in softtissue 102) formed from the suture material 2000, wherein the toggle2004 is positioned in the “locked” orientation relative to the suturebody 2002 to prevent the end of the suture body 2002 coupled to thetoggle 2004 from pulling back through into the soft tissue 102.

FIG. 22 is a flow diagram of an illustrative method 2200 for fixing softtissue to an attachment surface, in accordance with various embodiments.The operations of the method 2200 may be discussed below with referenceto the helical suture 400, but the method 2200 may be performed to fixsoft tissue to an attachment surface using any desired helical suture.

At 2202, a helical suture may be provided in soft tissue. The softtissue may have a longitudinal axis along which the soft tissueundergoes tension under normal physiological conditions, and alongitudinal axis of the helical suture in the soft tissue may beoriented parallel to the longitudinal axis of the soft tissue. Forexample, as illustrated in FIGS. 6-8, a helical suture 400 may beprovided in soft tissue 102. The soft tissue 102 may have a longitudinalaxis 104 along which the soft tissue 102 undergoes tension under normalphysiological conditions. A longitudinal axis 410 of the helical suture400 in the soft tissue 102 may be oriented parallel to the longitudinalaxis 104 of the soft tissue 102. The soft tissue may be, for example, atendon. In some embodiments, the helical suture may include at least twoturns of suture material. In some embodiments, the helical suture mayhave a turn angle between 20 degrees and 60 degrees (e.g., 45 degrees).

At 2204, the helical suture may be secured to an attachment surface. Theattachment surface may be, for example, a bone, other soft tissue, orany of the other example attachment surfaces discussed herein. Forexample, as illustrated in FIG. 6-8, the helical suture 400 may besecured to an anchor 106 in a bone 180.

Other operations may be included in the method 2200 in variousembodiments. For example, the method 2200 may further include providinga second helical suture in the soft tissue, wherein a longitudinal axisof the second helical suture is oriented parallel to the longitudinalaxis of the first helical suture. The method 2200 may also includesecuring the second helical suture to the attachment surface. Such anembodiment is illustrated in, for example, FIGS. 6-8.

The operation 2202 may be performed in any of a number of ways. In someembodiments, providing the helical suture in the soft tissue may includeinserting a helix-shaped needle into the soft tissue, wherein suturematerial is secured to the needle, and rotating the helix-shaped needleto provide the helical suture in the soft tissue. For example, thehelix-shaped needle 902 or 1408 may be deployed into the soft tissue 102and rotated to form the helical suture 400 from suture material (e.g.,the suture material 2000) secured to the helix-shaped needle. In someembodiments, a helix-shaped needle may be manually rotated in the softtissue (e.g., as discussed above with reference to the insertioninstrument 900) or may be rotated by a mechanical instrument (e.g., asdiscussed above with reference to the insertion instrument 1400).

The insertion instruments disclosed herein (e.g., the insertioninstrument 900 and the insertion instrument 1400) may be disposable orreusable, and/or may have disposable or reusable components. Forexample, the needle assembly 1430 of the insertion instrument 1400 maybe disposable, while the remainder of the insertion instrument 1400 maybe reusable.

As noted above, the helical sutures 400 and related devices andtechniques disclosed herein may be advantageously applied to fix softtissue to any suitable attachment surface. For example, FIGS. 23-24 areviews of a soft tissue-to-soft tissue repair using helical sutures 400,in accordance with various embodiments. In particular, FIG. 23illustrates two portions of soft tissue 102 separated by a tear or otherinjury, with each portion having a helical suture arrangement 2300disposed thereon. The helical suture arrangement 2300 may include one ormore helical sutures 400 provided in the portions of soft tissue 102(e.g., using any of the devices or techniques disclosed herein) suchthat the longitudinal axes of the helical sutures 400 are parallel tothe longitudinal axis of the soft tissue 102 (e.g., as discussed abovewith reference to FIGS. 6-8). The pattern of helical sutures 400 in thehelical suture arrangement 2300 may be mirrored in each of the portionsof the soft tissue 102 so that each helical suture 400 has acorresponding helical suture 400 in the other portion of the soft tissue102. Free ends 2302 of suture material may extend from the helicalsutures 400.

FIG. 24 depicts a helical suture arrangement 2400 to achieve the repairof the soft tissue 102 by joining the two portions of the soft tissue102 and tying the free ends 2302 of the corresponding helical sutures400 of the portions of the soft tissue 102 into a knot (or otherwisesecuring the free ends 2302 of the corresponding helical sutures 400 toeach other). The helical suture arrangement 800 is thus an example of asoft tissue-to-soft tissue repair using the helical sutures 400, and thesystems and methods disclosed herein may be used in any similar or othersuitable settings.

FIGS. 25-26 are cross-sectional side views of the operation of agripping mechanism of the insertion instrument 1400 of FIGS. 14-19 and3200 of FIGS. 32-36, in accordance with various embodiments. Inparticular FIG. 25 depicts gripping teeth 2508 of the gripping portion1414 in an open configuration 2500 and FIG. 26 depicts the grippingteeth 2508 in a closed or gripping configuration 2600. The grippingportion 1414 includes push rods 2502 in the needle chamber 1416 which,when translated in the direction indicated by the arrow 2504, cause thegripping teeth 2508 to rotate about the cross-pin axes 2506 and to“open.” When the push rods 2502 translate in the direction indicated bythe arrow 2604, the gripping teeth 2508 rotate in the opposite directionabout the cross-pin axes 2506 and the gripping teeth “close” on eachother to grip any soft tissue therebetween.

As discussed above, when the soft tissue undergoes deformation due totension forces and the helical suture 400 “lengthens” as a result, thehelical suture 400 directs the tension forces both normally (into thetissue “inside” the helical suture 400 to compress that tissue) andtangentially (in the directions tangent to the helical suture 400). Thisdistribution of forces may improve the “grip” of the helical suture 400on the soft tissue when the soft tissue undergoes tension, reducing thelikelihood of repair failure. This achieves a desirable redistributionof forces, and any braided or other suture geometry that achieves thisredistribution of forces under tension may be within the scope of thisdisclosure.

FIGS. 37A-39 are various views of helical sutures 400 disposed in thesoft tissue 102 using two helix-shaped needles, such as 902 or 2702where the direction of rotation of the helices of the two helix-shapedneedles is opposite. FIGS. 37A and 37B show two parallel sutures 420 and430, bridged by suture material 425. FIGS. 37A and 37B show two paralleland overlapping sutures 420 and 430, bridged by suture material 425.FIG. 39 shows suture 400 passing over and under soft tissue 102. The twosuture strands 420 and 430 are composed on a single suture filament. Onehelix-shaped needle have a direction of rotation is used to anchor thefirst strand, strand 420 in the soft tissue 102, a second helix-shapedneedle is then used to pick up the remaining suture material and guideit back through the soft tissue, strand 430. This configuration leavesno loose ends of suture except at the lateral edge of tendon requiringrepair of the soft tissue.

1. A method for fixing soft tissue of a subject to an attachment surface, comprising: inserting a helical suture having a longitudinal axis in the soft tissue of the subject, wherein the soft tissue has a longitudinal axis and wherein the longitudinal axis of the helical suture in the soft tissue is oriented parallel to the longitudinal axis of the soft tissue; and securing the helical suture to the attachment surface.
 2. The method of claim 1, wherein the soft tissue undergoes tension, under normal physiological conditions, along the longitudinal loading axis of the soft tissue.
 3. The method of claim 1, wherein the soft tissue comprises a tendon.
 4. The method of claim 1, wherein the attachment surface comprises bone.
 5. The method of claim 4, wherein the attachment surface comprises a humerus.
 6. The method of claim 1, wherein the helical suture comprises at least two turns of suture material.
 7. The method of claim 1, wherein securing the helical suture to the attachment surface comprises securing the helical suture to an anchor secured to the attachment surface.
 8. The method of claim 1, wherein the attachment surface comprises soft tissue, allograft material, xenograft material, or a synthetic material.
 9. The method of claim 1, wherein the helical suture comprises a turn angle between 20 degrees and 70 degrees.
 10. The method of claim 1, wherein the helical suture comprises a turn angle of approximately 45 degrees.
 11. The method of claim 1, wherein the helical suture is a first helical suture and the method further comprises: inserting a second helical suture in the soft tissue, wherein a longitudinal axis of the second helical suture is oriented substantially parallel to the longitudinal axis of the first helical suture; and securing the second helical suture to the attachment surface.
 12. The method of claim 11, wherein the first helical suture and second helical suture have opposite directions of rotations.
 13. The method of claim 11, wherein the first helical suture and second helical suture have the same direction of rotation.
 14. The method of claim 11, wherein the first helical suture and the second helical suture overlap.
 15. The method of claim 1, wherein inserting the helical suture in the soft tissue comprises: inserting a helix-shaped needle having a tip into the soft tissue; and rotating the helix-shaped needle to provide a helical channel in the soft tissue; securing suture material to the tip of the helix-shaped needle; and reversing a direction of rotation of the helix-shaped needle thereby inserting the helical suture in the soft tissue.
 16. The method of claim 16, wherein rotating the helix-shaped needle comprises: grasping, with a hand of a human operator, an insertion instrument comprising the helix-shaped needle; and rotating the insertion instrument with the hand.
 17. The method of claim 16, wherein rotating the helix-shaped needle comprises: linearly translating a slide component of an insertion instrument comprising the helix-shaped needle, wherein the linear translation of the slide component causes rotation of the helix-shaped needle.
 18. The method of claim 16, wherein linearly translating the slide component comprises linearly translating a trigger lever along the longitudinal axis of the helix-shaped needle.
 19. The method of claim 15, further comprising: gripping, with a gripping portion of an insertion instrument comprising a helix-shaped needle, the soft tissue; and pulling, with the gripping portion, the soft tissue toward and over the helix-shaped needle while the helix-shaped needle rotates.
 20. The method of claim 19, wherein the insertion instrument comprises a trigger lever extending perpendicularly from a longitudinal axis of the helix-shaped needle, rotating the trigger lever around the longitudinal axis of the helix-shaped needle causes the gripping portion to grip the soft tissue, and translating the trigger lever along the longitudinal axis of the helix-shaped needle and longitudinal axis of the helix-shaped needle causes the helix-shaped needle to rotate.
 21. The method of claim 15, wherein the helix-shaped needle is included in an insertion instrument having a rear handle, and the helix-shaped needle does not translate with reference to the rear handle when the helix-shaped needle is rotated to provide the helical suture in the soft tissue.
 22. The method of claim 1, wherein inserting the helical suture in the soft tissue comprises: inserting a helix-shaped needle into the soft tissue having suture material secured to the helix-shaped needle; and rotating the helix-shaped needle thereby inserting the helical suture in the soft tissue.
 23. An insertion instrument, comprising: a needle assembly having a helix-shaped needle and a body; a slide component in which the body of the helix-shaped needle is at least partially disposed; a trigger lever coupled to the slide component; and a rear handle, wherein linearly translating the trigger lever toward the rear handle causes the helix-shaped needle to rotate.
 24. The insertion instrument of claim 23, wherein the helix-shaped needle comprises at least two turns.
 25. The insertion instrument of claim 23, wherein the helix-shaped needle comprises a tip and a hook for securing suture material at the tip of the helix-shaped needle.
 26. The insertion instrument of claim 23, wherein the helix-shaped needle comprises a recess located along a length of the helix-shaped needle.
 27. The insertion instrument of claim 26, further comprising a suture disposed within the recess.
 28. The insertion instrument of claim 23, wherein the helix-shaped needle has a turn angle between 20 degrees and 60 degrees.
 29. The insertion instrument of claim 28, wherein the helix-shaped needle has a turn angle of approximately 45 degrees.
 30. The insertion instrument of claims 23, further comprising: a gripping portion coupled to the trigger lever, wherein rotating the trigger lever around a longitudinal axis of the helix-shaped needle causes the gripping portion to close.
 31. The insertion instrument of claim 30, wherein linearly translating the trigger lever toward the rear handle causes the gripping portion to linearly translate toward the rear handle.
 32. The insertion instrument of claim 30, wherein the helix-shaped needle does not translate with reference to the rear handle when the helix-shaped needle is rotated. 